FDA Inspection
Biomat USA IncBiomat USA Inc – FDA Inspection, Jun 5, 2009
Record Details
This FDA Inspection record concerns Biomat USA Inc, with an inspection on June 5, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomat USA Inc
- Inspection Date
- June 5, 2009
- Product Type
- Biologics
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ID · ecc33f92-1f64-41cd-8ec7-e5a39ac2a37b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 586398
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomat USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 29, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 27, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 24, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 18, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Biomat USA Inc
- FDA Inspection 1196124 - 2023-01-13
- FDA Inspection 1057142 - 2018-05-29
- FDA Inspection 969080 - 2016-04-27
- FDA Inspection 867478 - 2014-02-24
- FDA Inspection 753878 - 2011-11-18
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